The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Rheumatoid Factor Immunological Test System.
| Device ID | K102673 |
| 510k Number | K102673 |
| Device Name: | RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM |
| Classification | System, Test, Rheumatoid Factor |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin M Mann |
| Correspondent | Martin M Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | DHR |
| CFR Regulation Number | 866.5775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-16 |
| Decision Date | 2011-09-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010861 | K102673 | 000 |
| 07333066010854 | K102673 | 000 |
| 07333066014128 | K102673 | 000 |
| 07333066014111 | K102673 | 000 |